Trevena Inc (NASDAQ:TRVN) closed Thursday’s trading session at $1.41 and its stock price has been bullish ever since it revealed its regulatory update for Oliceridine and announced the receipts of Type A meeting minutes.
The company revealed on January 28 that the U.S Food And Drug Administration (FDA) provided it with the official minutes for their Type A meeting. The minutes are about Oliceridine’s New Drug Application (NDA) Complete Response Letter (CRL) and the FDA’s complete response letter. It has also been revealed that the FDA is on board with Trevena’s safety database.
The FDA will also support the treatment’s labeling at a 27 mg maximum daily dose. The U.S regulatory authority has also given Trevena the green light to conduct a study that will include healthy subjects so that it can compile the required QT interval data. The study will feature positive-control and placebo arms.
“We are encouraged by the productive discussion with FDA, which we believe has provided a path to resubmit the oliceridine NDA” stated Trevena CEO, Carrie L. Bourdow.
The biopharma plans to submit a detailed analysis and protocol plan to the FDA sometime soon. It also expects to kick off the study within the first half of 2019 once it receives feedback from the FDA. Bourdow also noted that Trevena will remain committed to its mission of facilitating access to effective and safe treatments for patients who need IV opioid to manage their pain.
Trevena will present at 21st Annual BIO CEO & Investor Conference in February
Trevena also recently announced that it will be among the firms that have scheduled presentations at the 21st Annual BIO CEO & Investor Conference. The event will take place at the New York Marriott Marquis in New York on February 12 and Trevena will present at 9:15 a.m. EST. The presentation will also be available as a live audio webcast that will be available on the investor section of Trevena’s website. It will also feature playback for 30 days which means it will still be available for those that will not manage to catch up with the live event.